Drugs

Apply Covid Lessons to Other Diseases: Drug Companie

Writing for the Global Forum, authors from 12 major drug companies say it is time to apply the sense of urgency that was used to quickly develop Covid-19 vaccines and treatments to other diseases of significant public health burden. “Cardiovascular and neurological diseases are both associated with even greater morbidity and mortality compared to Covid-19,” the group’s paper says. “We cannot ignore the lasting social and economic impact of other highly prevalent, serious diseases. The time for this international and permanent shift, applying a selective, enhanced benefit/risk framework to systematically leverage tools across all stages of development, is now. If health authorities applied this same approach to other highly prevalent and serious illnesses, new therapies could be brought to the market sooner and incrementally lead to further innovation and improved public health.”

The paper calls for:

public and private stakeholders to align globally on a transparent set of criteria and regulatory guidance for identifying and developing treatments for diseases with the most significant impacts on public health that could benefit from such an approach;
clear communication of the rationale for the disease state(s) selected and the magnitude of impact the disease(s) will continue to have on public health without targeted intervention; and
internationally harmonizing best practices and effectively communicating them to the industry.

“Regulatory flexibilities during the pandemic, including use of enhanced risk-based regulatory frameworks, quickly produced life-saving advancements,” the paper concludes. “If health authorities similarly applied this approach to other highly prevalent, serious illnesses, new therapies could be brought to the market sooner. If we truly learn from our experience with Covid-19 and apply that knowledge, the future of medicine is within reach.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome